Description

Lamivudine Impurity 2 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Lamivudine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for antiviral drug formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Lamivudine API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities.
• Quality Control & Assurance (QC/QA): A key component in routine batch release testing to ensure Lamivudine meets pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND), and new drug application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Item	Details
Product Name	Lamivudine Impurity 2
CAS No.	200396-21-0
Molecular Formula	C8H11N3O3S
Molecular Weight	229.26 g/mol
Synonyms	(-)-2',3'-Dideoxy-3'-thiacytidine Impurity 2; 3TC Impurity 2; (2R,5S)-5-(Cytosin-1-yl)-1,3-oxathiolane-2-carboxamide; Lamivudine Related Compound B; Epimer of Lamivudine; 3'-Thia-2',3'-dideoxycytidine Impurity; BCH-189 Impurity
EINECS	Contact for details

Quality Control

Every batch of Lamivudine Impurity 2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccator or under an inert atmosphere to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.